Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)

This study has been terminated.
(See termination reason in detailed description)
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01009593
First received: October 14, 2009
Last updated: September 7, 2012
Last verified: June 2012

October 14, 2009
September 7, 2012
January 2010
July 2012   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: From randomization until patient death; assessed monthly ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: From randomization until patient death; monthly ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01009593 on ClinicalTrials.gov Archive Site
  • Time To Progression (TTP) [ Time Frame: From randomization until patient progression; assessed every 6 weeks ] [ Designated as safety issue: No ]
  • Overall Response Rate (ORR) [ Time Frame: Assessed Every 6 weeks ] [ Designated as safety issue: No ]
  • Time to progression (TTP) [ Time Frame: From randomization until patient progression; assessed every 6 weeks ] [ Designated as safety issue: No ]
  • Objective Response Rate (ORR) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)
An Open-label, Randomized Phase 3 Study of the Efficacy and Tolerability of Linifanib (ABT-869) Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.

The IDMC recommended discontinuation of the study, and, the protocol was amended to end study treatment.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatocellular Carcinoma Non-resectable
  • Hepatocellular Carcinoma Recurrent
  • Carcinoma, Hepatocellular
  • Liver Diseases
  • Neoplasms by Histologic Type
  • Digestive System Neoplasms
  • Carcinoma
  • Liver Neoplasms
  • Neoplasms
  • Neoplasms by Site
  • Digestive System Diseases
  • Adenocarcinoma
  • Neoplasms, Glandular and Epithelial
  • Drug: ABT-869
    Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity
    Other Name: ABT-869
  • Drug: Sorafenib
    Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.
    Other Name: Sorafenib
  • Experimental: ABT-869
    Intervention: Drug: ABT-869
  • Active Comparator: Sorafenib
    Intervention: Drug: Sorafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1035
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Histologic or cytologic diagnosis with unresectable or metastatic HCC
  • Child Pugh Class A
  • ECOG performance status 0-1
  • Adequate hematologic, hepatic, and renal function

Exclusion Criteria

  • Prior systemic (administered intravenously or orally rather than locoregionally) treatment for HCC
  • Prior local therapy (including liver-directed therapy) within 4 weeks from entry
  • Untreated brain or meningeal metastases
  • Current treatment on another clinical trial
  • Pregnancy or breastfeeding
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Canada,   Chile,   China,   Czech Republic,   Denmark,   Egypt,   France,   Germany,   Greece,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Puerto Rico,   Romania,   Russian Federation,   Singapore,   Spain,   Taiwan
 
NCT01009593
M10-963, 2009-013435-38
Not Provided
Abbott
Abbott
Not Provided
Study Director: Justin Ricker, MD Abbott
Abbott
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP